Singapore HSA Streamlines Stability Data Requirements for Therapeutic Product Registration
Singapore HSA has revised the Guidance on Therapeutic Product Registration in Singapore and Related Appendices. The changes will take effect …
Malaysia NPRA Issues Directive on Registration and Enforcement of Cell and Gene Therapy Products(CGTPs) in Stages
On 14 Dec 2020, Malaysia NPRA issues Directive 19 of 2020 on Registration And Enforcement Of Cell And Gene Therapy Products(CGTPS …
Singapore HSA Singapore Launches New Digital Health Webpage
HSA launched this webpage in December 2020 as a one-stop portal to encourage innovation in the area of digital health …
Korea MFDS announces obligation to use E2B (R3) for electronic transmission of Individual Case Safety Reports from June 2021
On 30 November 2020, the Korean Ministry of Food and Drug Safety (MFDS) has issued a press report titled “To …
Australia TGA to Allow Registration of Over-The-Counter Low Dose Cannabidiol
Australia Therapeutic Goods Administration (TGA) announced on 15 December 2020 a final decision to down-schedule certain low dose cannabidiol (CBD) preparations from …
China CDE Revised Procedures for Drug R&D and Technical Review Communication and Discussion with Applicant
China CDE has issued an updated version of “Administrative Measures for Drug R&D and Technical Review Communication and Discussion ” …
Taiwan FDA Issues eCTD Specifications and Validation Criterion
In order to promote Taiwan’s adoption of ICH Electronic Common Technical Document (eCTD) format of , applicants will be able …
Hong Kong DoH has updated the Guidance Notes for Overview of the Medical Device Administrative Control System
On 4 November 2020, the Hong Kong Department of Health has issued a new version of Guidance Notes: GN-01 Overview …
Q&A on Implementation of Chinese Pharmacopeia 2020
The Chinese Pharmacopoeia Commission has published a Q&A on the Implementation of 2020 Chinese Pharmacopeia on 30 September 2020. The …